CLASS II ONGOING Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
Rifampin Capsules, USP, 150 mg recalled by Akorn
Akorn is recalling Rifampin Capsules, USP, 150 mg, distributed nationwide in the US. The recall was initiated on 21 Sep 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1547-2022
- FDA event ID
- 90880
- Recalling firm
- Akorn, Gurnee, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Sep 2022
- FDA classified
- 28 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 21 Sep 2022 | Recall initiated by company | |
| 28 Sep 2022 | Classified by FDA | +7 days |
| 5 Oct 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Where it was distributed
USA Nationwide and Puerto Rico
Questions about this recall
Is Rifampin Capsules, USP, 150 mg recalled?
Yes. Akorn recalled Rifampin Capsules, USP, 150 mg on 21 Sep 2022. The recall is Class II and its status is Ongoing. Recall number D-1547-2022.
Why was it recalled?
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Which lots are affected?
Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
Where was it sold?
USA Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Rifampin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rifampin Capsules USP, 300mg recalled by Lupin Pharmaceuticals | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Rifampin Capsules USP 300mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
| Drug | CLASS II | Rifampin Capsules USP, 150 mg doses recalledRifampin | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
| Drug | CLASS II | Rifampin Capsules USP, 150 mg recalled by Akorn | Akorn | Sterility | Nationwide |